Trends of Mastectomy and Breast-Conserving Surgery in Female Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Trends of Mastectomy and Breast-Conserving Surgery and Related Factors in Female Breast Cancer Patients Treated at King Abdulaziz University Hospital, Jeddah, Saudi Arabia, 2009-2017

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03762642
• Other study ID #: 357-71
• Status: Completed
• Start date: July 17, 2017
• Est. completion date: August 2, 2018

Study information

• Verified date: December 2018
• Source: King Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Breast cancer is the most common cancer in women across the world, accounting for 25.2% of cancer cases among females and 14.7% of cancer-related deaths among females worldwide. The survival rates are markedly lower in the developing countries compared to developed countries, as well as the age at diagnosis. Core management of breast cancer includes surgical removal of the tumor either by breast-conserving surgery (BCS) or mastectomy (removal of the whole breast). Choosing between these two procedures may be influenced by factors that have yet to be studied in Saudi Arabia. The investigators aimed to determine the prevalence of BCS and mastectomy and the factors that may influence the choice of procedure. This retrospective study was carried out by reviewing the records of female breast cancer patients who underwent BCS or mastectomy at King Abdulaziz University Hospital between 2009 to June 2017, excluding those with metastasis (distant spread of the cancer) or recurrence. Using frequencies for the rate, and multivariate tests, the investigators analyzed different demographic, clinicopathological, and radiological factors to detect correlations with procedure choice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: August 2, 2018
• Est. primary completion date: August 2, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Female, diagnosed with breast cancer, underwent surgery on the breast tumor in King Abdulaziz University Hospital

Exclusion Criteria:

• Patients with metastatic breast cancer or recurrence of the cancer before the surgery

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Female
• Breast Neoplasms

Intervention

Procedure:
• Mastectomy
Removal of the whole breast
• Breast-Conserving Surgery
Removal of the cancerous tissue only

Locations

Country	Name	City	State
Saudi Arabia	Faculty of Medicine	Jeddah	Mecca

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of each of mastectomy and breast-conserving surgery	The percentage of of patients who underwent each surgery	2009-2017
Secondary	The relationship between the choice of procedure and the patients' age (in years)	Statistical analysis using independent sample T-test and binary logistic regression	2009-2017
Secondary	The relationship between the choice of procedure and the use of preoperative chemotherapy (also called "neoadjuvant chemotherapy")	Statistical analysis using Chi-square test and binary logistic regression	2009-2017
Secondary	The relationship between the choice of procedure and the tumor's laterality (right versus left breast cancer)	Statistical analysis using Chi-square test and binary logistic regression	2009-2017
Secondary	The relationship between the choice of procedure and the tumor's focality (whether it is composed of more than one mass)	Statistical analysis using Chi-square test and binary logistic regression	2009-2017
Secondary	The relationship between the choice of procedure and the tumor's centricity (whether it involves more than one quadrant of the breast)	Statistical analysis using Chi-square test and binary logistic regression	2009-2017
Secondary	The relationship between the choice of procedure and the tumor's size (in centimeters)	Statistical analysis using independent sample T-test and binary logistic regression	2009-2017
Secondary	The relationship between the choice of procedure and the tumor's stage (using the 7th "American Joint Committee on Cancer"'s staging guidelines)	Statistical analysis using Chi-square test and binary logistic regression	2009-2017
Secondary	The relationship between the choice of procedure and the tumor's histological grade (using the Nottingham Histologic Score system)	Statistical analysis using Chi-square test and binary logistic regression	2009-2017
Secondary	The relationship between the choice of procedure and the tumor's receptor status (whether it is positive for estrogen, progesterone, and/or human epidermal growth factor receptor 2)	Statistical analysis using Chi-square test and binary logistic regression	2009-2017
Secondary	The relationship between the choice of procedure and having preoperative magnetic resonance imaging of the breast and its findings	Statistical analysis using Chi-square test and binary logistic regression	2009-2017